2015 Survey of Veterinarians About Compounding and FDA's draft guidance

Sun, 06/14/2015 - 20:04

Survey of veterinarians shows that proposed FDA guidance on the use of medications that are “very important” to their practices and to patients’ medical outcome would have a large negative impact on them and their patients.

A new poll of veterinary practices that administer and prescribe customized medications for their patients confirms that new guidance proposed by the Food & Drug Administration (FDA) would have a large negative impact on their practices and their patients’ health if issued and enforced. The poll was conducted between May 29 and June 12, 2015 shortly after FDA released its proposed “Guidance for Industry Compounding Animal Drugs from Bulk Substances” for public comment.

A coalition of compounding pharmacies that specialize in veterinary medicine commissioned the research to learn how practicing veterinarians would be affected if they were to apply FDA’s guidelines as detailed in the draft proposal. Although even if issued this draft FDA guidance is not binding on FDA, compounding pharmacies, or veterinarians and will not be the law, in the past FDA has used similar non-binding guidance as the basis for its enforcement actions against compounding pharmacies.

The survey reports on the responses of 2,359 veterinary professionals in the U.S., 73% of whom practice in small businesses with four or fewer veterinarians; 72% of respondents treat primarily companion animals. For 99% of those responding, having access to compounded medications when they are necessary in their medical judgment is important; 90% say it is “very important.” Their ability to maintain office stock of compounded medications to be administered as needed to patients is important” to their patients’ health and medical outcomes for 94% of those responding; 77% say it is “very important.” The FDA’s guidance recommends eliminating office use of compounded medications from compounding pharmacies.

In reality, 89% of respondents say that they order compounded medications for office stock, which they administer to patients often in emergency situations, from compounding pharmacies. However, of the respondents practicing in states that require patient-specific prescriptions for compounded medications, 78% say that this restriction has a negative impact on their ability to practice medicine.

The FDA guidance also includes sweeping new recommendations for writing prescriptions that would have some or a large negative impact for 81% of the practices responding. The FDA has no authority to regulate the practice of medicine. Yet, the guidance calls for a state-licensed prescriber to include a detailed explanation on each prescription about why the veterinarian did not prescribe an FDA-approved manufactured drug, to attest that there was no FDA drug that could have been prescribed instead, and to explain in detail why the compounded drug will produce a “clinical difference” for the patient. If the FDA guidance is adopted, veterinarians will be the only medical professionals FDA is directing to explain and justify how they are treating their patients.

If published, the FDA proposed guidance will have an impact on virtually all veterinary practices. The U.S A 2013 study on Veterinary Drug Compounding by Brakke Consulting, Inc. concluded that “the use of compounded medications is ubiquitous in small-animal veterinary medicine. Nearly every veterinarian has prescribed compounded drugs for a patient and the majority uses them regularly. The use of compounded medications is just as common in equine medicine as in companion-animal medicine.”